Post-Traumatic Stress Disorder (PTSD) and Seroquel
Functional Reciprocity Between Heightened Stress Reactivity and Emotional Numbing in PTSD: Novel Predictors of Pharmacotherapeutic Outcomes
1 other identifier
interventional
34
1 country
1
Brief Summary
This 8 weeks study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 8, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
May 30, 2017
CompletedMay 30, 2017
June 1, 2015
5.1 years
February 8, 2010
March 3, 2017
April 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in PTSD Symptomatology at the Week 8 Timepoint.
We will compare patients' symptomatology at baseline vs. at 8 week timepoint Specify Full Scale Name and Construct (i.e., indicate what the scale measures if not clear from name): Clinician-Administered PTSD Scale (CAPS) Include all scale ranges (i.e., minimum and maximum scores) required to interpret any values in the data table: 0-136 For each scale range provided, specify which values are considered to be a better or worse outcome: 0-best, 136 worst If subscales are combined to compute a total score, consider indicating how subscales are combined (summed, averaged, etc.): summed
8 weeks
Study Arms (1)
Seroquel
EXPERIMENTALThis study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Interventions
This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD
Eligibility Criteria
You may qualify if:
- Provision of written informed consent
- Fluency in English
- A diagnosis of PTSD
- No pregnancy
- Right-handedness
You may not qualify if:
- Pregnancy or lactation
- Any cognitive impairment that precludes informed consent
- Known intolerance or lack of response to Seroquel
- Previous enrollment or randomization of treatment in the present study
- Participation in another drug trial within 4 weeks prior enrollment into this study
- Patients with Diabetes Mellitus
- History of allergic reaction or hypersensitivity to Seroquel
- Contraindications to magnetic resonance imaging
- Treatment with an effective medication for PTSD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Central Street Health Center
Somerville, Massachusetts, 02143, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Igor Elman
- Organization
- Cambridge Health Alliance
Study Officials
- PRINCIPAL INVESTIGATOR
Igor Elman, MD
CHA
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
February 8, 2010
First Posted
February 10, 2010
Study Start
February 1, 2010
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
May 30, 2017
Results First Posted
May 30, 2017
Record last verified: 2015-06
Data Sharing
- IPD Sharing
- Will not share